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Report available - Madrid hosted EAPM round table on Tumour Agnostics, innovation, RWE and Molecular Diagnostics which took place at ESMO Congress, 2020

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The Brussels-based European Alliance for Personalised Medicine (EAPM) has held a key round table at the ESMO Congress in Madrid. The report is available by clicking here, writes EAPM Executive Director Denis Horgan.

The high-level discussions under the banner ‘EAPM seeks innovative solutions at ESMO for cancer patients’ held virtually in the Spanish capital, represented the eight such roundtables conducted by the Alliance at the Congress.   This type of interaction is one key aspect of EAPM’s stated goals - to engage with the medical community whenever possible, and at every level.

The round table comes at a crucial time as Europe deploys new efforts to bring innovation into healthcare systems and to establish strategic co-operation. EAPM is actively engaged in discussions with stakeholders and with policymakers on the emerging Beating Cancer Plan and the CancerMission, the promised EU health Data Space, the review of research incentives in its orphan drug rules, the overarching Pharmaceutical Strategy scheduled to appear before the end of 2020, and the new determination– announced in mid-September - to go beyond the draft EU4 Health programme and create a genuine European Health Union.

Attendees at the round table included patients, European Parliament politicians, European Medicine Agency, public health experts, economists, industry representatives from ICT and pharma-ceutical companies, and other specialists from across multiple disciplines.

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EDUCATION: EAPM’s multi-stakeholder, high-diversity meeting took into account the fact that new discoveries - generated from a deeper understanding of the human genome.  This shift is rapidly progressing in oncology but is slower in other areas. And, while there are many barriers to innova-tion in clinical practice - including market access, scientific, and/or regulatory challenges - the big-gest challenge across the healthcare system is continuing medical education for healthcare professionals. The report is available by clicking here

MOLECULAR DIAGNOSTICS, INCENTIVES AND MORE:  Topics discussed in depth were incentives and molecular diagnostics which were underpinned by our recent academic publication entitled: Bringing Greater Accuracy to Europe’s Health -care Systems: The Unexploited Potential of Biomarker Testing in Oncology, is already winning plaudits, and it can be read here.   This took into account the ongoing developments in the field of personalised medicine, such as DNA profiling, concepts of ‘va-lue’ and biomarkers and, because of the diversity of the disciplines of the delegates attending, the meeting constituted a bridge between new developments and those that will implement them, as well as the patients who will eventually benefit.

A CHANGING SOCIETY, WITH CHANGING NEEDS: As we all know, a key difference between personalised medicine and conventional methods of treating patients is the setting aside of a ‘one-size-fits-all’ philosophy in favour of a much more targeted process.   A major reason for this is the fact that patients respond differently to the same medicine being used to treat the ‘same’ disease.

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Cancer patients overall have a non-response rate of a massive 75 percent. This is for a disease that is the biggest healthcare cost burden of all, as well as being the biggest killer.  Meanwhile, sickness and disability costs form a large portion of GDP and government social spending while overall healthcare costs are rising all the time with Europe’s ageing population. Indeed, the average lifespan has increased by around 25 years in the space of a century.  Better adoption of molecular Diagnostic and early diagnosis can ensure a better rational allocation of resources in society to tackle this societal burden.

INNOVATION IS KEY: Tumour Agnostics and RWE

A major pillar in bringing new, targeted medicines to patients is, of course, innovation. This, in the realm of health, means the translation of knowledge and insight into what we can call ‘value’. And that value covers the value to patients but also has to take into account value to healthcare systems, society and, of course, the manufacturers. 

In the context of tumour agnostics, fittingly described by many speakers as a paradigm shift in cancer care,  tumour agnostic therapies present a new promise of precision medicine – and accordingly, as was frequently argued during the discussion, they require a new way of thinking about cancer care. They offer new opportunities for patients with rare mutations, and the pipeline of potential tumour agnostic therapies/ indications is growing rapidly.  

For the RWE evidence session, the discussion made clear that the simplicity of the concept of using RWE in healthcare belies the many complexities underlying its exploitation. Harnessing health data from many sources in real time should help faster and better medical decision-making. But it will not happen automatically, as the roundtable made clear

For each of the three round tables, the report includes recommendations.  Here is that link to the report again by clicking here

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German ICUs expect COVID peak to hit hospitals at Christmas

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Germany is likely to reach a peak of its fourth wave of COVID-19 infections by mid-December and this could mean 6,000 intensive care beds occupied by Christmas, the country's association for intensive care medicine (DIVI) said on Wednesday (1 December), write Paul Carrel and Emma Thomasson, Reuters.

Andreas Schuppert, a forecaster for the DIVI association, told a news conference he was "moderately optimistic" the peak in new cases would come in the next two weeks, but warned this would take time to have its full impact on hospitals.

"It is an ominous situation," DIVI president Gernot Marx told reporters. "We would be well advised to react immediately. We must get ahead of the situation."

About 4,600 intensive care beds are currently occupied by COVID-19 patients, compared with a previous high of 5,745 on Jan. 3 when Germany was in a full lockdown.

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However, the DIVI said a shortage of nursing staff means Germany now only has about 9,000 beds where patients can receive artificial respiration, down from 12,000 a year ago.

The Robert Koch Institute, Germany's state infectious disease agency, reported 67,186 new COVID-19 cases on Wednesday, up 302 from a week ago, and 446 deaths, the highest daily figure since Feb. 18 - bringing the overall death toll to 101,790.

However, the seven-day incidence rate per 100,000 fell for a second day to 442.9 people, from 452.2 people on Tuesday.

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Germany's federal and regional governments agreed on Tuesday to take action, including stepping up the vaccination campaign and restricting contact, especially for unvaccinated people.

Already criticised by scientists for acting too late, the leaders agreed to take firm decisions on Thursday on proposals such as compelling customers to show proof of vaccination or recovery in shops and limiting numbers of people at big events.

Four people in southern Germany have tested positive for the newly identified Omicron coronavirus variant even though they were fully vaccinated, the public health office in the state of Baden-Wuerttemberg said.

Three of the infected people returned from a business trip to South Africa on Nov. 26 and Nov. 27 respectively, and the fourth person is a family member of one of the returnees. All four showed moderate symptoms of COVID-19.

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ACI EUROPE urges governments to adhere to WHO guidance and reject blanket travel bans

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Airport trade body ACI EUROPE has given its strongest support to the World Health Organization’s call for a calm and measured response to the Omicron variant, and urged governments to react accordingly. Specifically, in its updated COVID-19 Travel Advice, the WHO states: "Countries should continue to apply an evidence-informed and risk-based approach when implementing travel measures. Blanket travel bans will not prevent the international spread, and they place a heavy burden on lives and livelihoods Europe’s airports are at the front line of a country’s travel policy. They have seen first-hand the dramatic and disproportionate impact of travel bans and other extreme travel restrictions - specifically quarantines - which have little effect upon the epidemiological situation."

The WHO’s unequivocal guidance to countries not to knee-jerk into travel bans is extremely welcome. The updated advice comes as ACI EUROPE welcomed the European Commission’s new travel regime proposals issued last week, which place the emphasis on a travellers’ health status rather than their country of departure. Societal and economic damage ensues when extreme travel restrictions such as those recently imposed by some countries override the lessons learned through the pandemic to date.

ACI EUROPE Director General Olivier Jankovecsaid: “We know beyond any doubt from the experience gained over these past 20 months that blanket travel bans and quarantines are not effective in preventing the spread of new variants. While they have no impact on the epidemiological situation, they do have dramatic consequences upon livelihoods. We urge all countries to follow the WHO advice and make sure they follow evidence-informed and risk-based approaches when reviewing their travel regimes, as part of precautionary measures in relation to the Omicron variant. In particular, targeted pre-departure testing should be preferred over travel bans and quarantines. Effective coordination and alignment at EU level involving all EEA countries, Switzerland and also the UK is a must”.

ACI EUROPE also pointed to the urgency of achieving greater rollout of vaccinations not just in Europe but globally. Jankovec commented: "It would be difficult not to link the emergence and spread of the Omicron variant with the current situation of global vaccination inequity – which painfully proves the point that 'nobody is safe until everybody is safe' as repeatedly said by Commission President von der Leyen. But that means the EU and other European countries must do much more to ensure COVAX gets vaccines swiftly to low income countries. This could also potentially require the EU to align with the US with a view to wave patents and other intellectual property rights on COVID-19 vaccines and treatments. Securing wider and fairer access to vaccination and therapeutics across the World is an absolute prerequisite to effectively mitigate the risk of other variants of concern emerging. The aviation and travel and tourism sectors are the most directly exposed to rebounds in the COVID-19 pandemic. We just can’t go on like that.”

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First suspected case of Omicron variant of COVID-19 detected in Switzerland

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The first probable case of the Omicron variant of COVID-19 has been detected in Switzerland, the government said late on Sunday (28 November), as the country tightened its entry restrictions to check its spread, writes John Revill, Reuters.

The case relates to a person who returned to Switzerland from South Africa around a week ago, the Federal Office for Public Health said on Twitter.

Testing will clarify the situation in the coming days, it added.

Switzerland has ordered that travellers from 19 countries must present a negative test when boarding a fight to the country, and must go into quarantine for 10 days on arrival.

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The list includes Australia, Denmark, Britain, Czech Republic, South Africa and Israel.

Swiss voters on Sunday backed the government's pandemic response plan by a bigger than expected majority in a referendum, paving the way for the continuation of exceptional measures to stem the rising tide of COVID-19 cases. Read more.

Some 62.01% voted in favour of a law passed earlier this year to provide financial aid to people hit by the COVID-19 crisis and laying the foundation for certificates giving proof of COVID-19 vaccination, recovery or a negative test. These are currently required to enter bars, restaurants and certain events.

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